Fracture Fixation Device

ABSTRACT

Assemblies for securing fractured bone are provided. The assembly includes a first fixation element, a second fixation element, and an adjustable flexible member construct. The first fixation element having a male or a female sleeve is secured within a first portion of the fractured bone. The second fixation element having the other of the male or female sleeve telescopically received within the one of the male or female sleeve is secured within a second portion of the fractured bone. The adjustable flexible member construct extends between the first and second fixation elements and has at least one adjustable loop coupled to the first fixation element and the second fixation element and a pair of adjusting ends extending through an opening in the first fixation element. The pair of adjusting ends can be pulled to reduce a diameter of the adjustable loop and to compress fragments of the fractured bone.

CROSS-RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/938,902 filed on Nov. 3, 2010, which is acontinuation-in-part of U.S. patent application Ser. No. 12/489,168filed on Jun. 22, 2009, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/474,802 filed on May 29, 2009, which is acontinuation-in-part of (a) U.S. patent application Ser. No. 12/196,405filed on Aug. 22, 2008; (b) U.S. patent application Ser. No. 12/196,407filed on Aug. 22, 2008; (c) U.S. patent application Ser. No. 12/196,410filed on Aug. 22, 2008; and (d) a continuation-in-part of U.S. patentapplication Ser. No. 11/541,506 filed on Sep. 29, 2006, which is nowU.S. Pat. No. 7,601,165 issued on Oct. 13, 2009.

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/570,854 filed on Sep. 30, 2009, which is acontinuation-in-part of U.S. patent application Ser. No. 12/014,399filed on Jan. 15, 2008.

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/702,067 filed on Feb. 8, 2010, which is a continuation ofU.S. patent application Ser. No. 11/541,505 filed on Sep. 29, 2006 andis now U.S. Pat. No. 7,658,751 issued on Feb. 9, 2010.

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/196,398 filed Aug. 22, 2008, which is a continuation-in-partof U.S. patent application Ser. No. 11/784,821 filed Apr. 10, 2007.

The disclosures of all the above applications are incorporated byreference herein.

FIELD

The present disclosure relates to devices and methods for fracturefixation, and more particularly to holding bone fragments together topermit healing.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

After trauma or surgical intervention, there may be a need to fix bonefragments together to immobilize the fragments and permit healing.Compressive force can be applied to the bone fragments by encircling thebone fragments or bridging the fragments together across a broken orotherwise compromised portion of the bone. The compressive forces shouldbe applied such that upon growth of new bone, the fragments will healtogether and restore strength to the trauma or surgical interventionsite.

Accordingly, there is a need for apparatus and methods to applycompressive force to a bone to affect healing. Further, there is a needfor an apparatus and related methods which are easy to useintraoperatively to accommodate various bone sizes, shapes, or locationsof fractures.

SUMMARY

In various embodiments, the present teachings provide an assembly forsecuring a fractured bone. The assembly includes a first fixationelement, a second fixation element, and an adjustable flexible memberconstruct. The first fixation element is secured within a first portionof the fractured bone and has one of a male or a female sleeve extendingwithin the fractured bone. The second fixation element is secured withina second portion of the fractured bone and has the other of the male orfemale sleeve extending within the fractured bone. The one of the maleor female sleeve is telescopically received within the other of the maleor female sleeve of the first fixation element. The adjustable flexiblemember construct extends between the first and second fixation elementsand has at least one adjustable loop coupled to the first fixationelement and the second fixation element, and a pair of adjusting endsextending through an opening in the first fixation element. The pair ofadjusting ends can be pulled to reduce a diameter of the adjustable loopand to compress fragments of the fractured bone.

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.

FIG. 1 depicts an assembly having a closed flexible member holder and anopen flexible member holder according to the present teachings;

FIG. 2 depicts a frame having two open flexible member holders and anadjustable flexible member construct according to the present teachings;

FIG. 3 depicts an elongated frame according to the present teachings;

FIG. 4 depicts an elongated frame having a plurality of flexible memberholders according to the present teachings;

FIGS. 5A through 5C depict frames defining openings to receive fastenersaccording to the present teachings;

FIGS. 6A and 6B depict adjustable flexible member constructs accordingto the present teachings;

FIG. 7 depicts an assembly compressing a fractured or weakened boneaccording to the present teachings;

FIG. 8 depicts an assembly compressing a fractured or weakened boneaccording to the present teachings;

FIG. 9 depicts an assembly compressing a fractured or weakened boneaccording to the present teachings;

FIGS. 10A and 10B depict a frame having a post extending therefromaccording to the present teachings;

FIG. 11 depicts a frame having a post extending therefrom used in anassembly according to the present teachings;

FIG. 12 depicts a frame having a post extending therefrom where theframe defines a plurality of openings to receive at least one fasteneraccording to the present teachings;

FIG. 13 depicts a side view of a surgical method according to thepresent teachings;

FIG. 14 depicts a top view of a surgical method according to the presentteachings;

FIGS. 15A-15D depict side views of fixation of a fracture in surgicalmethods according to the present teachings;

FIGS. 15E and 15F depict a section view of the screw assembly of FIG.15D;

FIGS. 16A and 16B depict a spinal repair using apparatus according tothe present teachings; and

FIGS. 17A-17D depict a bone repair using the screw assembly of FIG. 15D.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure, application, or uses. Itshould be understood that throughout the drawings, correspondingreference numerals indicate like or corresponding parts and features.While the present disclosure relates to fracture fixation, the apparatusand methods of the present teachings can be used with other orthopedicand non-orthopedic procedures as well.

Referring to FIGS. 1 and 2, an assembly 10 is provided according tovarious embodiments of the present teachings. The assembly 10 includes aframe 12 and an adjustable flexible member construct 14. As furtherdetailed below and as depicted in FIG. 7, regions of the adjustableflexible member construct 14 are partially disposed in the frame 12 suchthat the adjustable flexible member construct 14 and the frame encirclea bone 16 having fragments 18 and 18′ due to surgical intervention,injury, or disease. While the present disclosure may exemplify afractured bone, it is understood that any of the reasons for bonecompromise may be used with the present teachings. It is furtherunderstood that the frame 12 can be used in connection with other framesthat are placed on a different or opposing face of the bone 16. Thevarious embodiments disclosed herein can also be used to stabilize otherimplants, such as those used in revision surgery or for oncologicalpurposes.

In various embodiments, the assembly 10, assembly 110, 210 as detailedlater herein, or the adjustable flexible member construct 14 alone isused to compresses the respective fragments together and to affecthealing at the compromised bone 16. Bones suitable for use with thepresent teachings include any bone in the body, such as the vertebrae,long bones of the arms, legs or fingers; curved bones, such as the ribs;flat bones, such as those of the wrist or feet, for example, and thelike. Any bones of the legs, arms, torso, hands, feet, head, aresuitable for use with the apparatus and methods of the presentteachings.

Referring to FIGS. 1 through 5C, the frame 12 includes a lower surface20, an upper surface 22, and at least flexible member holders 24A and24B defined by projections on the upper surface 22. In variousembodiments, the frame 12 can be a one-piece, integral, monolithicstructure. In various embodiments, the frame 12 can be made of agenerally rigid material. The frame 12 can be made of a plastic orpolymeric material, a metal, or a composite thereof. The frame 12 can begenerally rectangular or square, or the frame 12 can be a rounded shapeor a site-specific shape. For example, the lower surface 20 can becurved to conform to the desired bone 16. The frame 12 can be of asufficient length to span across a region of both fragments 18 and 18′.The frame 12 can also span the entirety of the fractured area of thebone 16 and cover healthy adjacent bone 16, or the frame can be smallerthan the fractured area of the bone 16. The frame 12 can also beelongated such that it spans beyond the length of the fracture orweakened area, such as the frames 12 shown in FIGS. 3 and 4.

The frame lower surface 20 can include a flat surface or the lowersurface 20 can be curved to accommodate the contour of the bone 16. Theupper surface 22 of the frame 12 partially defines the openings 26A and26B for the flexible member holders 24A and 24B, respectively. Theflexible member holders 24A and 24B can be channels, a post, a pin, ahole, or other means by which to retain a flexible member on the frame12. It is understood that the flexible member holders 24A and 24B neednot be formed on the upper surface 22 and that the flexible memberholders 24A and 24B can extend from the lower surface 20 and around theupper surface 22. As shown in FIGS. 4 and 8, the frame 12 can include aplurality of flexible member holders 24A-24D which can be separated by aspace 28 between the sets of flexible member holders 24C and 24A, and24D and 24B. Although various embodiments disclosed may relate to onlytwo flexible member holders, it is understood that the processes of useare generally the same for assemblies having 2 through 8, or moreflexible member holders.

Any of the flexible member holders 24A-24D can be open such that theadjustable flexible member construct 14 can be repeatedly manuallyplaced and removed, or the flexible member holders 24A-24D can be closedsuch that the adjustable flexible member construct 14 is permanentlyhoused therein and cannot be inadvertently removed without disassemblingthe adjustable flexible member construct 14. The flexible member holders24A-24D can be sized to allow the adjustable flexible member construct14 to freely slide therein. The flexible member holders 24A-24D can bepre-formed to be closed or can be initially provided as an open andsubsequently crimped or pinched closed. FIG. 1 depicts the frame havingan open flexible member holder 24A and a closed flexible member holder24B while FIG. 2 depicts two open flexible member holders 24A and 24B.

In various embodiments, the flexible member holders 24A and 24B faceeach other or are opposed. This allows for the adjustable flexiblemember construct 14 to be disposed in a first flexible member holder,for example flexible member holder 24B, wrapped around the bone 16, andthen be disposed in the other flexible member holder, for exampleflexible member holder 24A, and tightened when the flexible memberconstruct 14 is engaged such that opposing force is applied to theopposing flexible member holder to provide compression.

As shown in FIGS. 3 through 5C and FIGS. 8 and 9, the frame 12 candefine at least one opening 30 in which to attach a fastener 32 such asa pin, screw, spike, or a combination or variation thereof to bone. Theframe 12 can include a plurality of fastener openings 30 to accommodatemultiples of the same or different fasteners 32. The fastener openings30 can be placed along the periphery of the frame 12 as shown in FIGS.5A through 5C, or the fastener openings 30 can cut through the lowersurface 20 and upper surface 22 of the frame 12. The fastener openings30 can be evenly placed on or about the frame 12, as shown in FIG. 5Band FIG. 9, or they can be asymmetrically placed on or about the frame12, as shown in FIG. 5A. It is understood that the fastener openings 30can be placed anywhere along the frame 12 at any angle and can be placedwithin the interior of the frame 12.

Referring to FIG. 1, the frame 12 can be used to hold the adjustableflexible member construct 14 as depicted in FIGS. 6A and 6B. Theadjustable flexible member construct 14 is fashioned from a flexiblemember 34 made of any biocompatible material that is flexible and canfold around and secure the bone 16. Exemplary materials include, but arenot limited to, non-resorbable polymers, such as polyethylene orpolyester, resorbable polymers, metals, and various combinationsthereof. The materials can include those formed into a monofilament,multiple filaments, cables, and the like. In various embodiments, theadjustable flexible member construct 14 is made of a hollow material toallow for the appropriate folding and tensioning. In variousembodiments, the adjustable flexible member construct 14 can be asuture. In such embodiments, the suture can be hollow or a braided ormultiple-filament suture structure. In various embodiments, theadjustable flexible member construct 14 can define a substantiallytubular hollow shape.

To form the adjustable flexible member construct 14, a first end 36 ofthe flexible member is passed through a first aperture 38 and through alongitudinal passage 40 and out a second aperture 42. A second end 44 ispassed through the second aperture 42, through the longitudinal passage40 and out the first aperture 38. In various embodiments, the first andsecond apertures 38 and 42 are formed during the braiding process asloose portions between pairs of fibers defining the flexible member 34.Passing the ends 36 and 44 through the apertures 38 and 42 forms loops46 and 46′. The longitudinal and parallel placement and advancement ofthe first and second ends 36 and 44 of the flexible member 34 within thelongitudinal passage 40 resists the reverse relative movement of thefirst and second portions 48 and 50 of the flexible member 34 once it istightened. A further discussion of the flexible member construct isprovided in U.S. patent Ser. No. 11/541,506 filed on Sep. 29, 2006entitled “Method And Apparatus For Forming A Self-Locking AdjustableSuture Loop” assigned to Biomet Sports Medicine, Inc., and thedisclosure is incorporated by reference.

The loops 46 and 46′ define mounts or summits 52 and 52′ of theadjustable flexible member construct 14 and are disposed opposite fromthe longitudinal passage 40 such that when the summit 52 is disposed ina first flexible member holder 24A and the longitudinal passage 40 isdisposed in a second flexible member holder 24B, the summit 52 and thelongitudinal passage 40 remain stationary with respect to the frame 12,while the overall diameter of the adjustable flexible member construct14 is decreased to compress the bone fragments 18 and 18′.

The tensioning of the ends 36 and 44 cause relative translation of thesides of the flexible member 34 with respect to each other. Uponapplying tension to the first and second ends 36 and 44 of the flexiblemember 34, the size of the loop(s) 46 is reduced to a desired size orload. The flexible member 34 locks without knots due to the tensioningplaced on the first and second ends 36 and 44. At this point, additionaltension causes the body of the flexible member defining the longitudinalpassage 40 to constrict about the portions 48 and 50 of the flexiblemembers within the longitudinal passage 40. This constriction reducesthe diameter of the longitudinal passage 40, thus forming a mechanicalinterface between the exterior surfaces of the first and second portions48 and 50, as well as the interior surface of the longitudinal passage40. This constriction causes the adjustable flexible member to“automatically” lock in a reduced or smaller diameter position.

In use, the assembly 10 is formed by coupling the adjustable flexiblemember construct 14 to the frame 12. The lower surface 20 is placed suchthat it abuts the bone fragments 18 and 18′. In embodiments where atleast one flexible member holder 24A or 24B is closed, the summit 52 isplaced in the open flexible member holder 24B opposite the longitudinalpassage 40 disposed in the opposing closed flexible member holder 24A.The flexible member free ends 36 and 44 are engaged and pulled in thedirection of the arrow shown in FIG. 7 such that the diameter of theloop 46 is reduced and the bone fragments 18 and 18′ are compressed. Inembodiments where the longitudinal passage 40 is not pre-disposed in theclosed flexible member holder 24A or where both flexible member holdersare open, the longitudinal passage 40 and the summit 52 are placed inthe respective, opposing flexible member holder and then the free ends36 and 44 are engaged to tighten the adjustable flexible memberconstruct 14 and secure the bone fragments 18 and 18′. No additionalsteps, such as knot tying, are required to secure the adjustableflexible member due to the automatic locking feature.

Turning to FIGS. 10A through 15C, in still other embodiments, anassembly 110 is provided. The assembly 110 shares several similaritieswith the assembly 10 detailed above. It is understood that the assembly110 and the assembly 10 can have interchangeable features and thediscussion of separate features on the respective assemblies is notintended to be a limitation of the present teachings.

The assembly 110 includes a frame or fixation plate 112 and anadjustable flexible member construct 114. The frame 112 includes a lowersurface 120, an upper surface 122, and at least one flexible memberholder, depicted as a post 124, thereon about which the adjustableflexible member construct 114 can be secured.

The post 124 sits proud to the upper surface 122 of the frame. The post124 can be centered on the frame 112, or the post 124 can be placed atan off-center point on the frame 112. The post 124 can be generallysmooth and cylindrical as shown in FIGS. 10A and 10B, or the post 124can be a squared or have any other suitable geometry. The post 124 caninclude surface features by which the adjustable flexible memberconstruct 114 can be disposed in or through, such as a notch, under cut,groove, or throughbore. An exemplary under cut or notch 126 is shown inFIG. 10A.

The frame 112 can have a flat profile or the frame 112 can have aslightly curved profile, such as those shown in FIGS. 10A and 10B,respectively. As shown in FIG. 12, for example, the frame 112 can defineopenings 130 to receive fasteners 132 such as those detailed earlierherein. Although a plurality of evenly spaced fastener openings 130 aredepicted on the frame 112 in FIG. 12, it is understood that the fasteneropenings 130 can be placed anywhere along the periphery of the frame112, can be placed through the center of the post 124, or can beasymmetrically placed. The fastener openings 130 can also be threaded toreceive screws. In various embodiments, the fastener openings 130 caninclude both machine threads and bone engaging threads.

In use, the lower surface of the frame 112 is placed against the bonefragments 18 and 18′. Either of the summit 52 or the longitudinalpassage 40 of the adjustable flexible member construct 14 is disposedabout the post 124. The other of the summit 52 or the longitudinalpassage 40 is partially circled about the bone 16 and is disposed on theopposite side of the post 124. In embodiments where the post 124includes the notch 126, the adjustable flexible member construct 14 canbe disposed in the notch 126 during the wrapping process. The ends 36and 44 of the adjustable flexible member construct 14 are engaged toreduce the diameter of the adjustable flexible member construct 14 aboutthe bone 16 and thereby compress the bone fragments 18 and 18′.

Turning to FIGS. 15A-15D, in various embodiments, the assembly 210 caninclude an upper fixation element 200 and a lower fixation element 202having the adjustable flexible member construct 14 spanning therebetweenthrough an opening 204 formed in the bone fragments 18 and 18′. Theupper fixation element 200 and lower fixation element 202 canindependently be selected from a grommet 206, a toggle 208, a button209, a screw tip 212, a screw head 214, a set screw head 216, or othersimilar items. The screw elements (e.g., the screw tip 212, the screwhead 214, and the set screw head 216) may be provided with self-tappingthreads to omit the need for an additional tapping operation. As withthe frame 12, the assembly 210 can be made of a generally rigidmaterial, such as a plastic or polymeric material, a metal, or acomposite thereof. Any of the elements of the assembly 210 can also beformed from a porous material for bony ingrowth. In any embodiment,however, the material of the assembly 210 should be formed from abiocompatible material.

As shown in FIG. 15A, the upper fixation element 200 is the grommet 206and the lower fixation element is the toggle 208. The toggle 208 is usedto hold the longitudinal passage 40 of the adjustable flexible memberconstruct 14 and the opposing region is contained by the grommet 206 inbone fragment 18. The adjusting arms 36 and 44 are also passed throughthe grommet 206 and can be pulled to tighten the adjustable flexiblemember construct 14 and compress the bone fragments 18 and 18′ together.In particular, the grommet 206 may define a loop portion 218 and acentral cavity 220. The summit 52 may be disposed in the loop portion218 opposite the longitudinal passage 40 disposed in the opposing toggle208. The ends 36, 44 may pass on either side of the loop portion 218 andextend through the central cavity 220. In operation, the ends 36, 44 maybe engaged and pulled in the upward/outward direction such that thediameter of the loop 46 is reduced and the bone fragments 18 and 18′ arecompressed so as to be self-locking. While the adjustable flexiblemember construct 14 is shown and described as a single loop construct(FIG. 6A), it should also be understood that adjustable flexible memberconstruct 14 may have a double loop construct (FIG. 6B).

The upper fixation element 200 and lower fixation element 202 are shownin connection with the fixation plate 112 where the grommet 206 isdisposed in the opening 130 in the fixation plate 112. It is understoodthat the plate 112 can be used with either of the upper fixation element200 or the lower fixation element 202. When used with the grommet 206,however, a portion of the bone fragment 18′ may be reamed so as toprovide a countersink 222 for receipt of at least the loop portion 218.In particular, the countersink 222 may be sized so as to allow a topsurface 224 of the grommet 206 to lie flush with a top surface 226 ofthe fixation plate 112 after tightening.

FIGS. 15B, 15C, and 15D depict assemblies without the fixation plate 112shown in FIG. 15A. Similar to the previously discussed embodiment, anopening 204 is prepared in the bone fragments 18 and 18′. The opening204 is a partial opening and does not extend all of the way through bothbone fragments 18 and 18′.

With specific reference to FIG. 15B, the button 209 is used as the upperfixation element 200 and the screw tip 212 serves as the lower fixationelement 202. The lower fixation element 202 (i.e., the screw tip 212)may have an eyelet structure 228 for retaining the longitudinal passage40 of the adjustable flexible member construct 14. The screw tip 212 maybe fixed into the bone fragment 18. At least the free ends 36 and 44 andthe summit 52 of the adjustable flexible member construct 14 aredisposed through the button 209, through lacing for example, and can beadjusted to provide the secured fit and bone fragment 18 and 18′fixation. In particular, the ends 36, 44 may be engaged and pulled inthe upward/outward direction such that the diameter of the loop 46 isreduced and the bone fragments 18 and 18′ are maintained in a compressedposition. While the adjustable flexible member construct 14 is shown anddescribed as a single loop construct (FIG. 6A), it should also beunderstood that adjustable flexible member construct 14 may have adouble loop construct (FIG. 6B). In such a case, the summit 52′ mayextend through the same holes as the summit 52. Furthermore, while thebutton 209 is shown as having a 4-hole arrangement, it is alsocontemplated that only 2 holes may be present. In a 2-hole arrangement,both summits 52, 52′ and the ends 36, 44 may extend through the sameholes.

Turning to FIG. 15C, the upper fixation element 200 is depicted as thetelescoping screw head 214, and the lower fixation element 202 as thescrew tip 212. The screw tip 212 may be fixed in the bone fragment 18for retaining the longitudinal passage 40 of the adjustable flexiblemember construct 14, as described above. A sleeve member 230 may belocated between the upper and lower fixation elements 200, 202 so asprovide a telescoping arrangement for the screw head 214. The sleevemember 230 may be an individual element or may be integrally formed withthe screw tip 212. The telescoping screw head 214 may have a crossdrilled hole 232 for receiving the summit 52 and a central aperture 234for receiving the adjustable free ends 36 and 44 of the adjustableflexible member construct 14. When tightening the adjustable flexiblemember construct 14 as previously described, the telescoping screw head214 can be aligned with the sleeve member 230 and can be compressedtowards the distally placed screw tip 212 to secure the fracture. Thesleeve member 230 prevents side movement of the screw head 214 duringtightening and compression of the fracture.

With reference now to FIG. 15D, the upper fixation element 200 of theassembly 210 is depicted as the set screw head 216 either flush with orinset below an outer surface of the bone fragment 18′, while the lowerfixation element 202 is depicted again as the screw tip 212. The setscrew head 216 may be provided with a female sleeve 236 extending withinthe bone fragment 18′, while the screw tip 212 may be provided with thesleeve member 230 extending within the bone fragment 18. In this way,the male sleeve 230 of the screw tip 212 may be telescopically receivedwithin the female sleeve 236 of the set screw head 216.

It should be understood that sleeves 230, 236 may be either integrallyformed or separately formed and later secured to the set screw head 216or screw tip 212, respectively. It should also be understood that themale-female telescoping arrangement may be reversed so as to provide themale portion at the set screw head 216 and the female portion at thescrew tip 212. Additionally, the set screw head 216 and screw tip 212may each have an external screw thread wherein the outer threaddiameters may be similar, as shown, or may be provided with differentdiameter profiles to accommodate a particular fracture zone (e.g., theouter diameter of the set screw head 216 may be greater than the outerdiameter of the screw tip 212). With either outer diameter arrangement,the assembly 210 is fixed in the bone fragments 18 and 18′ such that theupper fixation element 200 is secured within the bone fragment 18′ andthe lower fixation element 202 is secured within the bone fragment 18,as will be described in more detail below with respect to FIGS. 17A-17D.

The adjustable flexible member construct 14 may extend between the upperand lower fixation elements 200, 202, as described above. In particular,the adjustable flexible member construct 14 may have the longitudinalpassage 40 passing through the eyelet structure 228 of the screw tip212, while at least the summits 52, 52′ may pass through a central plate234 in the set screw head 216. For example, the central plate 234 mayhave a plurality of apertures 238 for receiving at least the summits 52,52′ and ends 36, 44, as shown. For example, the ends 36, 44 may passthrough a first pair of apertures 240, while the summits 52, 52′ maypass through a second pair of apertures 242 in the set screw head 216,as shown in FIG. 15E. Conversely, the ends 36, 44 and the summits 52,52′ may commonly pass through the first pair of apertures 240 of the setscrew head 216, as best shown in FIG. 15F. While described as having acentral plate 234, it should be understood that any arrangement forreceiving the summits 52, 52′ and ends 36, 44 may be appropriate. Forexample, the upper fixation element 200 may have a solid body with atleast two apertures extending therethrough or the upper fixation elementmay have an enlarged upper bore with a plate-like piece inserted thereinfor retaining the summits 52, 52′.

As previously described, the ends 36, 44 may be engaged and pulled inthe upward/outward direction such that the diameter of the loop 46 isreduced and the bone fragments 18 and 18′ are compressed. The ends 36,44 may be tied so as to resist the reverse relative movement of thefirst and second portions 48 and 50 of the flexible member 34 once it istightened. While the adjustable flexible member construct 14 is shown asdescribed with reference to FIG. 6B, other constructs may be used incombination with the upper and lower fixation elements 200, 202 such asthose described in U.S. Pat. No. 7,601,165 to Stone, issued Oct. 13,2009, and is incorporated by reference in its entirety herein.

With reference now to FIGS. 15E and 15F, the female sleeve 236 may havean internally keyed surface 244 corresponding to an externally keyedsurface 246 of the male sleeve 230. For example, the externally keyedsurface 246 of the male sleeve 230 may be in the shape of a protrusion248 (FIG. 15E) or may be in the shape of a polygon, such as a hexagonalarrangement 250 (FIG. 15F). In this way, both the upper and lowerfixation elements 200, 202 may be rotationally driven at the same time.In particular, a hexagonal driver (not shown) may be inserted into anon-cylindrical or faceted upper drive bore 252 in the set screw head216. The hexagonal driver may provide a torque for rotation the setscrew head 216 into the bone fragment 18′, while the mated internallykeyed surface 244 and the externally keyed surface 246 may rotate thescrew tip 212 through the bone fragment 18′ and into the bone fragment18 simultaneously. Alternatively, the upper and lower fixation elements200, 202 may be separately driven into the bone fragments 18, 18′.

The present teachings further provide methods for securing the fracturedor weakened bone 16 within a patient's body. The frame 12 is abuttedagainst the fractured or weakened bone 16 such that the lower surface 20sits against the bone. The frame 12 can be positioned to span acrossboth sides of the fracture. The summit 52 or the longitudinal passage 40is disposed in one of the flexible member holders 24A or 24B defined bythe frame 12. The fractured or weakened bone 16 is then encircled bypartially wrapping the adjustable flexible member construct 14 at leastpartially contained in the frame about the bone. The other of the summit52 or the longitudinal passage 40 is fixed in the second, opposingflexible member holder 24B. In embodiments where a plurality of frames12 or the plurality of flexible member holders 24A-24D are provided onthe frame 12, the process can be repeated by employing severaladjustable flexible member constructs 14 in various sets of flexiblemember holders, for example the set 24A/24C and the set 24B/24D of FIG.4 and FIG. 8. The process can also be repeated by wrapping a singleadjustable flexible member construct 14 about the area to engage severalflexible member holders on the different frames, such as where theframes are used in tandem across a fractured or weakened bone.

The ends 36 and 44 of the adjustable flexible member construct 14 areengaged or pulled to reduce the size of the loop 46 and to cause thesummit 52 and the longitudinal passage to press against the respectiveopposed flexible member holders. This compresses the bone fragments 18and 18′ at the compromised site. In embodiments where the frame 12 ismade of a rigid material, engaging the free ends 36 and 44 does notcause the frame 12 to stretch, lengthen, or otherwise increase in size,thereby allowing for tighter compression. In embodiments utilizingfasteners 32 or 132, the fasteners can be secured to the bone fragments,18 and 18′ before or after the adjustable flexible member construct 14is reduced about the bone 16. The flexible member constructs allowadditional tensioning of each individual flexible member constructindependently, so as to avoid any laxity that may occur to a flexiblemember construct as others are tightened.

In still further embodiments such as those shown in FIGS. 16A and 16B,the frame 112 can be attached via a pedicle screw 134 which is affixedto vertebra 136. The pedicle screw 134 is passed through the fasteneropening 130 which is defined by the post 124. The pedicle screws 134 canbe linked together using the adjustable flexible member construct 14. Asshown in FIG. 16B, a single adjustable flexible member construct 14 canbe attached to two or more assemblies 10. Alternatively, as shown inFIGS. 16A and 16B, multiple adjustable flexible member constructs 14 canbe attached to one or more pedicle screws 134.

With reference now to FIGS. 17A-17D, a method for securing a fracturedbone using the assembly 210 shown in FIG. 15D, is described. Inparticular as shown in FIG. 17A, an aimer (not shown) may be used toguide a guide wire 260 through a selected portion of the fractured bone16. Appropriate aimers are generally known and need not be described indetail herein. Also, other techniques for placing the guide wire 260 inthe fractured bone 16 are also generally known and not described indetail herein. For example, such a device and method is described inU.S. Pat. No. 7,736,364, Stone, issued Jun. 15, 2010, and isincorporated by reference in its entirety herein. It will also beunderstood that the procedure may be augmented with an arthroscope (notshown) that may be passed through an appropriate incision in the softtissue surrounding the fractured bone 16.

After removal of the aimer, a longitudinal bore 262 of a cannulated bonecutting tool (e.g., drill 264) may be placed over the guide wire 260 toguide the bone cutting tool 264 as it is brought into engagement withthe fractured bone 16, as shown in FIG. 17B. The bone cutting tool 264may be used to drill an aperture 266 within at least a portion of thefractured bone 16. For example, the bone cutting tool 264 may drillthrough the bone fragment 18′ and into a portion of the bone fragment18. The guide wire 260 may then be removed from the fractured bone 16.

With reference now to FIG. 17C, the assembly 210 may be inserted intothe aperture 266. In particular, a driver (not shown) may be insertedinto the upper drive bore 252 of the set screw head 216 for rotationtherewith. Rotation of the set screw head 216, in turn, provides atorque to the screw tip 212 through the keyed surfaces 244, 246, causingit to translate through the bone fragment 18′ and into the bone fragment18, as previously described. Notably, the assembly 210 may bepre-assembled such that the longitudinal passage 40 of the adjustableflexible member construct 14 is passed through the eyelet structure 228of the lower fixation element 202, at least one summit 52 or 52′ of theadjustable flexible member construct 14 is passed through the upperfixation element 200, and the ends 36, 44 of the adjustable flexiblemember construct 14 extend through the corresponding loop portion 238 inthe upper fixation element 200.

Referring now to FIG. 17D, the adjustable flexible member construct 14may then be reduced for compressing the fractured bone 16. Inparticular, the ends 36, 44 of the adjustable flexible member construct14 may be engaged such that a distance between the upper and lowerfixation elements 200, 202 is decreased and the adjustable flexiblemember construct 14 automatically remains in a reduced position withinthe fractured bone 16. During this reduction, the male sleeve member 230of the lower fixation element 202 is telescopically received within thefemale sleeve member 236 of the upper fixation element 200.

The description of the invention is merely exemplary in nature and,thus, variations that do not depart from the gist of the invention areintended to be within the scope of the invention. For example, any ofthe above mentioned surgical procedures is applicable to the repair ofother body portions. For example, the procedures can be equally appliedto orthopedic repair of wrists, fingers, legs, ankles, and other bonesand also to non-orthopedic repairs. Such variations are not to beregarded as a departure from the spirit and scope of the invention.

1. An assembly for securing a fractured bone comprising: a firstfixation element configured to be secured within a first portion of thefractured bone, the first fixation element having one of a male or afemale sleeve extending from the first fixation element; a secondfixation element configured to be secured within a second portion of thefractured bone, the second fixation element having the other of the maleor female sleeve extending from the second fixation element andtelescopically received within the other of the male or female sleeve ofthe first fixation element; and an adjustable flexible member constructextending between the first and second fixation elements, the adjustableflexible member construct having at least one adjustable loop coupled tothe first fixation element and the second fixation element and a pair ofadjusting ends, wherein at least one of the adjusting ends can be pulledto reduce the adjustable loop and to compress fragments of the fracturedbone.
 2. The assembly of claim 1, wherein the first fixation element andthe second fixation element are selected from a grommet, a toggle, abutton, a screw tip, a screw head, or a set screw head.
 3. The assemblyof claim 1, wherein the first fixation element and the second fixationelement each have an external screw thread.
 4. The assembly of claim 3,wherein an outer diameter of the first fixation element is greater thanan outer diameter of the second fixation element.
 5. The assembly ofclaim 1, wherein the first and second fixation elements are configuredto be inset below an outer surface of the fractured bone.
 6. Theassembly of claim 1, wherein the sleeve of the first fixation elementhas a first keyed surface corresponding to a second keyed surface of thesleeve of the second fixation element.
 7. The assembly of claim 6,wherein the first keyed surface is one of a protrusion, recess, or apolygon.
 8. The assembly of claim 6, further comprising a drivemechanism in the first fixation element configured to drive both thefirst and second fixation elements by way of the first and second keyedsurfaces.
 9. The assembly of claim 1, wherein the adjustable flexiblemember construct comprises a hollow braided or woven structure having afirst of the pair of adjusting ends passed through a first aperture andthrough a longitudinal passage portion and out a second aperture to formthe at least one adjustable loop.
 10. The assembly of claim 9, wherein asecond of the pair of adjusting ends is passed through the secondaperture and through the longitudinal passage portion and out the firstaperture to form a second adjustable loop, the second adjustable loopcoupled to the first and second fixation elements.
 11. The assembly ofclaim 1, wherein the female and male sleeves are integrally formed withthe first and second fixation elements.
 12. The assembly of claim 1,wherein the first fixation element defines at least two apertures sizedto receive the pair of adjusting ends and the at least one adjustableloop.
 13. A method for securing a fractured bone comprising: aligningfirst and second portions of the fractured bone; forming a bore at leastpartially extending through the first and second portions of thefractured bone; inserting an assembly having a first fixation element, asecond fixation element, and an adjustable flexible member extendingbetween the first and second fixation elements into the bore, theadjustable flexible member having at least one adjustable loop coupledto the first fixation element and the second fixation element and a pairof adjusting ends; and reducing the adjustable flexible member constructto compress the fractured bone by pulling at least one of the adjustingends to reduce the adjustable loop.
 14. The method of claim 13, whereininserting the assembly into the bore comprises: rotationally keying thefirst fixation element relative to the second fixation element; placinga driver into an upper surface of the first fixation element; androtating the driver to simultaneously drive the first and secondfixation elements.
 15. The method of claim 13, wherein reducing theadjustable flexible member construct to compress the fractured bonecomprises: engaging the adjusting ends of the adjustable flexible memberconstruct such that a distance between the first and second fixationelements is decreased and the adjustable flexible member constructautomatically remains in a reduced configuration within the fracturedbone.
 16. The method of claim 13, wherein reducing the adjustableflexible member construct to compress the fractured bone comprises:telescopically positioning a sleeve member of the first fixation elementwith a sleeve member of the second fixation element.
 17. The method ofclaim 13, further comprising before inserting the assembly: passing alongitudinal passage of the adjustable flexible member through thesecond fixation element; passing the at least one loop of the adjustableflexible member through a portion of the first fixation element; andextending the pair of adjusting ends of the adjustable flexible memberthrough an opening in the first fixation element.
 18. The method ofclaim 13, wherein inserting the assembly into the bore furthercomprises: arranging the first fixation element so as to be one of insetor flush within the first portion of the fractured bone; and arrangingthe second fixation element so as to be one of inset or flush within thesecond portion of the fractured bone.
 19. An assembly for securing afirst portion and a second portion of a fractured bone comprising: afirst fixation member having one of a male or female sleeve, a firstcoupling member and an external screw thread configured to be rotatablyreceived within the first portion of the fractured bone; a secondfixation member having the other of the male or a female sleeve, asecond coupling member, and an external screw thread configured to berotatably received within the second portion of the fractured bone,wherein the male sleeve is telescopically received within the femalesleeve; and an adjustable flexible member construct extending betweenthe first and second fixation members, wherein the adjustable flexiblemember construct has at least one looped portion coupled to the firstfixation member and the second fixation member and first and second endspassing through the second coupling member, wherein at least one of thefirst and second ends can be pulled to reduce a diameter of the at leastone looped portion and to compress the first and second portions of thefractured bone.
 20. The assembly of claim 19, wherein the female sleeveis rotationally keyed to the male sleeve.
 21. The assembly of claim 19,wherein the female and male sleeves are integrally formed and extendfrom the respective first and second fixation members.
 22. The assemblyof claim 21, wherein the adjustable flexible member construct comprisesa hollow braided or woven structure having the first end passed througha first aperture and through a longitudinal passage portion and out asecond aperture to form the at least one looped portion, where thelongitudinal passage portion is attached to the first coupling member ofthe first fixation member.
 23. The assembly of claim 22, wherein thesecond end is passed through the second aperture and through thelongitudinal passage portion and out the first aperture to form a secondlooped portion.
 24. The assembly of claim 19, wherein the first couplingmember is an eyelet and the second coupling member is a central plate.